Company
Healthcare
Sr.ClinicalResearchAssociate
Neural analysis suggests this role is
optimal for Mid candidates.
“Sr. Clinical Research Associate. Skills: clinical site monitoring, site monitoring, project management, regulatory compliance, GCP, site relationship management. Manage, deliver and/or perform full clinical site monitoring services. design and oversight of project monitoring services”
Industry & Context.
resolution of site/patient issues
Ability to regularly travel to sites, Regular travel is required
What They're Looking For.
Must Have
college diploma/degree, 4-6 years of related experience, Self-motivation, communication skills, commitment to achieving positive results, attention to detail, keenness to understand the importance of building collaborative relationships to achieve results, Critical thinking abilities, Ability to regularly travel to sites
What You'll Do.
deliver and/or perform full clinical site monitoring services
design and oversight of project monitoring services
site/patient recruitment
site data/document management
monitoring project site budgets
act as primary liaison between CRAs and project team
participate in the development of project plans
communications or other monitoring forms
Act as subject matter expert
coach and/or provide performance feedback to manager for peers
Assist with selection
and supervision of CRAs
Perform co-monitoring and training visits with CRAs
act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns
manage monitoring services for a group of projects and/or CRAs on large/complex project(s)
directing/guiding day to day activities
review/approval of monitoring reports
escalating concerns and issues to management
participate and/or present at study team
kickoff and investigator meetings
act as primary contact to sponsors for all monitoring related issues
Identify and recruit site investigators
coordinate the movement and delivery of trial materials
Ensure SOPs in place to optimize patient recruitment
providing guidance to site teams of inclusion/exclusion criteria
Primary clinical site contact
act as primary contact for any questions or issues that arise from investigational sites
Oversee overall integrity of the study
promote positive working relationships with the site and staff
Facilitate and support site staff with access to study systems
ensure sites are compliant with project specific training requirements
Ensure all site related issues are followed until resolution
Coordinate delivery of clinical sites communications
ensure investigational sites are provided accurate ongoing data
information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle
How You'll Work.
Team & Collaboration
act as primary liaison between CRAs and project team; Function as liaison between CRAs and other functional teams; collaborating with project teams
Communication Scope
communication skills; primary liaison; primary contact; communications
Process & Methodology
Manage, deliver and/or perform full clinical site monitoring services, oversight of project monitoring services, development of project plans, manage monitoring services for a group of projects and/or CRAs on large/complex project(s), directing/guiding day to day activities, review/approval of monitoring reports, escalating concerns and issues to management, Coordinate delivery of clinical sites communications
Full Job Description
## Description Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale. In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices. In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders. ## Monitoring - Subject Expert Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers. Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs. When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns. May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus. ## Project Monitoring Lead May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports. Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed. Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues. ## Site Recruitment and Setup Identify and recruit site investigators, coordinate the movement and delivery of trial materials, sample
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